Assessment of Potential Interactions Between Intravenous... | NCT00265265

Studies
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

NCT00265265

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 12, 2017Estimated

Enrollment

Phase

Phase 1

Conditions

Cocaine-Related Disorders

Interventions

Atomoxetine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Not provided

First Submitted Date

Dec 13, 2005

First Submission Date that Met QC Criteria

Dec 13, 2005

First Posted Date

Dec 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Atomoxetine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety
Cardiovascular responses

Secondary Outcomes

Measure	Description	Time Frame
Cocaine craving
pharmacokinetic assessment
Psychological Effects of Cocaine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-45 years of age who are not seeking treatment at the time of the study
Must be able to provide written informed consent
Must be within 20 percent of ideal body weight and weigh at least 45 kg
Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
Must currently be using cocaine as confirmed by a positive BE
If female and of child bearing potential, must agree to the use of birth control

Exclusion Criteria:

- please contact the site directly for more information

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis Cantilena, M.D.	Uniformed Services University of Health Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniformed Services University of Health Science		Bethesda	Maryland	20814 4799	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22987022	Result	Cantilena L, Kahn R, Duncan CC, Li SH, Anderson A, Elkashef A. Safety of atomoxetine in combination with intravenous cocaine in cocaine-experienced participants. J Addict Med. 2012 Dec;6(4):265-73. doi: 10.1097/ADM.0b013e31826b767f.

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals